Morphine Sulfate

ANDA 202310, held by Chartwell Molecular. Morphine Sulfate.

As of Nov 15, 2026, ANDA 202310 (Morphine Sulfate), held by Chartwell Molecular, was first approved by FDA on Oct 30, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 30, 2015
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 30, 2015	Original application	Approved	REMS Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Morphine Sulfate20MG/5ML · solution;oral	Morphine Sulfate	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Feb 10, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Sep 18, 2018	Supplement 2REMS · Standard review	Approved	None posted
Oct 30, 2015	Original application	Approved	REMS Letter

Identifiers

Application: ANDA 202310
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters